Facial Skin Health Tracking Feasibility in Breast Cancer Patients

Breast Cancer Female Clinical Trial

Official title:

Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04035408
• Other study ID #: 18-2444.cc
• Status: Withdrawn
• Start date: January 24, 2020
• Est. completion date: February 13, 2023

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.

Description:

There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision to sign and date the consent form

2. Stated willingness to comply with all study procedures and be available for the duration of the study

3. Be a pre or perimenopausal woman age 18 or over

4. Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment

Exclusion Criteria:

1. Postmenopausal status (one year without a menstrual period)

2. Pregnant women (pregnancy test not required)

3. Prior cancer diagnosis of any type other than breast cancer

4. History of prior treatment with chemotherapy or radiation therapy

5. Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis

6. Use of a retinoid-based prescription facial skin product within the past 11 month

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Skin health assessment
Assess and measure the natural history of facial skin changes in pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of compliance in each of the 4 assessment tools	defined as the percentage of patients completing all the scheduled assessments under each assessment tool. The percentage of compliance will be summarized and the associated 90% confidence interval reported. If the percentage of compliance is 80% or higher under each assessment tool, the study will be considered feasible.	3 years
Secondary	Changes in skin health over the duration of the study (4 assessment points)	Difference in skin health at each assessment from baseline will be calculated which will be divided by the standard deviation of the difference to obtain the effect size of the change at each assessment time post baseline	3 years
Secondary	Changes in body image / skin QOL at end of treatment compared to baseline	Skindex16 will be used to assess. Skin traits will be rated from 0 (never bothered) to 6 (always bothered). The max score being 96, the least being 0.	3 years